MAUDE Adverse Event Report: ELUTIA INC. ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE; CANGAROO RM ANTIBACTERIAL ENVELOPE

Model Number	CMCV-124-MED
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It is noted that per the instructions for use (ifu - art20837 rev.A, ifu elupro antibiotic-eluting bioenvelope) provided with the finished elupro device, "infection" is listed within the potential complications associated with device usage.Infection is a known complication with the implant of a cardiac implantable device.
Event or Problem Description
Email was received from an elutia sales representative regarding a patient adverse event.It was reported that, the patient had a pocket revision with a crtd biv pacemaker implant on (b)(6) 2025 along with the implant of a medium elupro antibiotic-eluting bioenvelope (model - cmcv-124-med, lot number - unknown).The sales representative noted that the patient had an infection on (b)(6) 2025.The device was removed on (b)(6) 2025 and a new device was implanted on (b)(6) 2025.On (b)(6) 2025, the physician confirmed that the elupro device was not the cause of the infection.No further information regarding this event iwas provided.

• Brand Name: ELUPRO ANTIBIOTIC-ELUTING BIOENVELOPE
• Common Device Name: CANGAROO RM ANTIBACTERIAL ENVELOPE
• Manufacturer (Section D): ELUTIA INC.; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer (Section G): ELUTIA INC.; 1100 old ellis road; ste. 1200; roswell GA 30076
• Manufacturer Contact: michael hennick ; 1100 old ellis road; ste 1200; roswell, GA 30076 ; 4705144023
• MDR Report Key: 22911269
• Report Number: 3005619880-2025-00009
• Device Sequence Number: 9184501
• Product Code: FTM
• UDI-Device Identifier: 00859389005331
• UDI-Public: 00859389005331
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K233991
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CMCV-124-MED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Male